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1. (WO2005068493) VACCIN CONTRE L'ANTHRAX SOUS LA FORME D'UNE SPORE
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CLAIMS

1. A non-pathogenic spore comprising an antigenic fragment of anthrax protective antigen.

2. A spore as defined in claim 1 which is a Bacillus species spore; preferably a spore from one or more of the following organisms: Bacillus alvei; Bacillus badius; Bacillus brevis; Bacillus cereus; Bacillus coagulans; Bacillus fastidiosus; Bacillus lichetiiformis ; Bacillus mycoides; Bacillus pasteurii; Bacillus sphaericus; Bacillus aneurinolyticus; Bacillus carotarum; Bacillus fiexus; Bacillus freudenreichi; Bacillus macroides; Bacillus similibadius; Bacillus thiaminolyticus; Bacillus subtilis; Bacillus pumilus; Bacillus vallismortis; Bacillus bengalicus; Bacillus fiexus; and/or Bacillus licheniformis; more preferably a spore from Bacillus subtilis.

3. A spore as defined in claim 1 or claim 2 which comprises an antigenic fragment of anthrax protective antigen in the form of a protein attached to the proteinaceous coat of the spore.

4. A spore as defined in any one of the preceding claims which comprises an antigenic fragment of anthrax protective antigen encoded in the form of DNA which is adapted to be expressed when the spore germinates.

5. A spore as defined in any one of the preceding claims wherein the antigenic fragment is one or more of:
PA83 which is SEQ ID No. 6;
PA63 which is SEQ ID No. 7;
Domain 1 of the protective antigen which is SEQ ID No. 1 ;
Domain 2 of the protective antigen which is SEQ ID No. 2;

Domain 3 of the protective antigen which is SEQ ID No. 3;
Domain 4 (residues 595-735) of the protective antigen which is SEQ ID No. 4; and
Domain Dlb23 which is SEQ ID No. 10.

6. A spore substantially as hereinbefore described.

7. A spore as defined in any one of the preceding claims which is for use as an anthrax vaccine.

8. A pharmaceutical composition comprising a non-pathogenic spore comprising at least an antigenic fragment of anthrax protective antigen in association with a pharmaceutically acceptable carrier and/or excipient.

9. A composition as defined in claim 8 wherein the spore is a Bacillus species spore; preferably a spore from one or more of the following organisms: Bacillus alvei; Bacillus badius; Bacillus brevis; Bacillus cereus; Bacillus coagulans; Bacillus fastidiosus; Bacillus licheniformis; Bacillus mycoides; Bacillus pasteurii; Bacillus sphaericus; Bacillus aneurinolyticus; Bacillus carotarum; Bacillus fiexus; Bacillus freudenreichi; Bacillus macroides; Bacillus similibadius; Bacillus thiaminolyticus; Bacillus subtilis; Bacillus pumilus; Bacillus vallismortis; Bacillus bengalicus; Bacillus fiexus; anal ox Bacillus licheniformis; more preferably a spore from Bacillus subtilis .

10. A composition as defined in claim 8 or claim 9 wherein the spore comprises at least an antigenic fragment of anthrax protective antigen in the form of a protein attached to the proteinaceous coat of the spore.

11. A composition as defined in any one of claims 8 to 10 wherein the spore comprises at least an antigenic fragment of anthrax protective antigen encoded in the form of DNA which is adapted to be expressed when the spore germinates.

12. A composition as defined in any one of claims 8 to 11 which comprises an antigenic fragment of anthrax protective antigen, preferably the fragment is one or more of:
PA83 which is SEQ ID No. 6;
PA63 which is SEQ ID No. 7;
Domain 1 of the protective antigen which is SEQ ID No. 1;
Domain 2 of the protective antigen which is SEQ ID No. 2;
Domain 3 of the protective antigen which is SEQ ID No. 3;
Domain 4 (residues 595-735) of the protective antigen which is SEQ ID No. 4; and
Domain Dlb23 which is SEQ ID No. 10.

13. A composition as defined in any one of claims 8 to 12 which further comprises an adjuvant which potentiates an antigen- specific immune response.

14. A composition as defined in any one of claims 8 to 13 wherein the spore is substantially as hereinbefore described.

15. A composition as defined in any one of claims 8 to 14 for use as an anthrax vaccine.

16. Use of a non-pathogenic spore comprising at least an antigenic fragment of anthrax protective antigen in the manufacture of a vaccine for anthrax for non-parenteral administration, preferably for nasal and/or oral administration.

17. Use according to claim 16 wherein the spore is as defined in any one of claims 9 to 12.

18. Use of a composition as defined in any one of claims 8 to 15 in the manufacture of a vaccine for anthrax.

19. Use of a spore as defined in any one of claims 1 to 7 in the manufacture of a vaccine for anthrax.

20. Use as defined in claim 18 or claim 19 wherein the vaccine is for non-parenteral administration, preferably for nasal and/or oral administration.

21. A method of inducing immunity to anthrax in a mammal susceptible to anthrax infection which method comprises non-parenteral administration, preferably nasal or oral administration of an effective amount of a vaccine comprising a non-pathogenic spore comprising at least an antigenic fragment of anthrax protective antigen.

22. A method as defined in claim 21 wherein the spore is as defined in any one of claims 9 to 12.

23. A method of inducing immunity to anthrax in a mammal susceptible to anthrax infection which method comprises administration of an effective amount of a vaccine comprising a spore as defined in any one of claims 1 to 7 or of a composition as defined in any one of claims 8 to 15.

24. A method as defined in claim 23 wherein the vaccine is for non-parenteral administration, preferably for nasal and/or oral administration.